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FDA Approves VELCADE(R) (Bortezomib) for Injection for Patients with Previously Untreated Multiple Myeloma
Date:6/20/2008

cles of oral melphalan (M) plus prednisone (P) or MP plus VELCADE. Patients received M (9 mg/m2) plus P (60 mg/m2) daily for four days every 6 weeks or the same MP schedule with bortezomib (1.3 mg/m2) IV on days 1, 4, 8, 11, 22, 25, 29 and 32 of every 6 week cycle for 4 cycles then once weekly for 4 weeks on days 1, 8, 22 and 29 of every 6 week cycle for 5 additional cycles. Antiviral prophylaxis was recommended for patients on the VELCADE study arm. Time-to-progression (TTP) was the primary efficacy endpoint. Overall survival (OS), progression-free survival (PFS) and response rate (RR) were secondary endpoints. A total of 682 patients were randomized: 338 to receive MP and 344 to receive the combination of bortezomib plus MP. The median age of patients for both groups was 71 years. Demographics and baseline disease characteristics were similar between the two groups.

The safety profile of VELCADE in combination with MP is consistent with the known safety profiles of both VELCADE and MP.

In VISTA, the most commonly reported adverse events for VELCADE in combination with MP vs MP, respectively, were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), vomiting (33% vs 16%), pyrexia (29% vs 19%), fatigue (29% vs 26%), lymphopenia (24% vs 17%), anorexia (23% vs 10%), asthenia (21% vs 18%), cough (21% vs 13%), insomnia (20% vs 13%), edema peripheral (20% vs 10%), rash (19% vs 7%), back pain (17% vs 18%), pneumonia (16% vs 11%), dizziness (16% vs 11%), dyspnea (15% vs 13%), headache (14% vs 10%), pain in extremity (14% vs 9%), abdominal pain (14% vs 7%), paresthesia (13% vs 4%), herpes zoster (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% v
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SOURCE Millennium Pharmaceuticals
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